Quality Systems

Somnath Mishra, Somnath.mishra@shabas.net, is president at Shabas Solutions LLC.

William Hauck is senior associate at Shabas Solutions LLC.

Zachary Royal, is senior consultant at Shabas Solutions LLC.

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

Articles

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 

Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records.

Frequently Asked Questions about Batch Records

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

Element’s New Air Treatment Testing Facility Supports Indoor Space Public Health Air Quality

Jennifer Markarian is manufacturing editor of BioPharm International.

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality. 

Streamlining Equipment Quality and Flexibility

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Industry experts discuss best practices for certificates of analysis.

The Role of CoAs in Supplier Oversight

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Principles of Equipment Qualification

Single-use systems can benefit from standardized risk assessment and analysis protocols, which can facilitate the way in which processing equipment components are compared.

Considerations for E&L Analysis in Single-Use Systems

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

USP Revises Drug Compounding Chapters

Aloka Srinivasan, PhD is vice-president, Regulatory Services, Lachman Consultant Services, Inc.

Chuck Lambert, PhD, DABT, ERT is principal toxicologist at Intrinsik Ltd.

The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.

Nitrosamides–Should They Be Treated the Same as Nitrosamines?

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

CBER maps modernization plan to handle surge in research and applications. 

Quality Assurance/Quality Control